Real World Evidence Versus Quality of Test Study Results in Diagnostics for Coronary Heart Disease


Wahler S1, Jacobsohn N2, Kommer W3, Remde K4, Müller A5
1St. Bernward GmbH, Hamburg, Germany, 2Privatpraxis für Kardiologie Tegel, Berlin, Germany, 3Kardiologische Ordination Wolkersdorf, Wolkersdorf, Austria, 4Internistische Privatpraxis Dienerowitz & Remde, Heidelberg, Germany, 5Analytic Services GmbH, München, Germany

OBJECTIVES : Coronary artery disease (CAD) is still the most common cause of death globally. Chest pain is the most common sign of CAD. Around 90% patients showing up in German GP offices with chest pain suffer not from CAD. Ultra-sensitive phonocardiography (CADScore®, Acarix A/S) is a new technology to aid early rule-out of CAD to avoid more invasive or expensive diagnostic. To support cost-effectiveness modelling, Real world data had been collected, to prove the representativity of clinical trials results.

METHODS : Patient demographics and test results with ultra-sensitive phonocardiography (USP) had been collected retrospectively in four German/Austrian cardiologic outpatient offices between 2017 and 2020. Comparative dataset was a major trial for test quality DanNICAD-1, performed in two Danish hospitals between 2014 and 2016.


1,030 examinations with USP were collected from real world (RW) versus 1,501 in DanNICAD-1 trial (TR). Average age: RW 59.1y (±12.4), TR 57.2y (±8.7); gender: RW 53.7% male, TR 51.7% male; BMI: RW 26.4 (±4.6), TR 26.7 (±4.1), systolic blood pressure: RW 136.0 mmHg (±21.8), TR 138.5 mmHg (±18.7), diastolic: RW 81.6 mmHg (±11.6), TR 82.9 mmHg (±10.9); current smokers: RW:11.9%, TR 15.5%; dyslipidemia: RW 49.5%, TR 37.3%; diabetes: RW 17.1%, TR 5.3%. Symptoms typical angina: RW 13.5%, TR 27.4%; atypical angina: RW 43.4%, TR 34.9%; non-angina pain: RW 33.1%, TR 38.6%. Diamond-Forrester low: RW 12,6%, TR 14.3%, intermediate-low: RW 71.4%, TR 57.4%, intermediate-high: RW 14.0%, TR 25.8%.

In RW 46.5% of USP-test resulted in rule-out, TR 39.4%. Test-statistics sensitivity: RW 93.9%, TR 85.0%, specificity: RW 44.4%, TR: 42.1%; negative predictive value: RW 99.2%, TR 96.1%.

CONCLUSIONS : Ultra-sensitive phonocardiography has proven to be a clinically relevant diagnostic measurement in clinical trials. The use in real world demonstrated that neither patient demographics nor test results differ relevantly from the trial setting. Real world data could be used for further economic modelling.

Conference/Value in Health Info

2020-11, ISPOR Europe 2020, Milan, Italy

Value in Health, Volume 23, Issue S2 (December 2020)




Clinical Outcomes, Real World Data & Information Systems

Topic Subcategory

Clinical Outcomes Assessment, Reproducibility & Replicability


Cardiovascular Disorders

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